Effect of Isotonic Seawater Solution on Nasal Patency in Athletes: an Interventional Randomized Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Peak nasal inspiratory flow
研究概览
简要总结
Nasal patency is an important component of performing exercises because it helps in humidifying, heating and filtering the inhaled air. However, many athletes and exercisers experience difficulty breathing through their nose, which can affect their breathing and performance. Namely, during sports activities and greater physical effort, there is increased air flow, which causes significant dehydration and cooling of the mucous membrane of the upper respiratory system. This dehydration is associated with the release of inflammatory mediators, which can ultimately lead to narrowing of the airways (eg in athletes with asthma). However, in all athletes, regardless of whether they have asthma or not, damage to the airways can occur because during exercise, hyperpnea exposes the respiratory epithelium to increased physical forces and pressure, which leads to the risk of exfoliation of the previously dehydrated epithelial cells of the nose and even their complete separation. Repeated stretching and compression can negatively affect the functionality of the epithelium and, with repeated exposure and damage, lead to structural and functional changes.
Rinsing the nose with a hypertonic or isotonic solution of seawater is a potential solution for nasal obstruction because after rinsing, the airflow through the nose improves and symptoms of obstruction are reduced. However, the effects of using nasal lavage solutions along with exercise in elite athletes are not yet known. The potential synergy of exercise and isotonic seawater solution as a nasal spray on airflow and the subjective impression of nasal patency in healthy individuals has not been sufficiently investigated5.
Research question
What is the effect of an isotonic seawater solution applied as a nasal spray on nasal airflow and the subjective impression of nasal obstruction in healthy athletes?
Hypothesis
An isotonic seawater solution applied as a nasal spray will improve nasal airflow and the subjective impression of nasal obstruction in healthy athletes.
详细描述
Subjects and Methods
Participants:
50 healthy adult athletes between the ages of 18 and 35 will be engaged in the research (power analysis with 80% power and an alpha error of 5% shows that 32 subjects in two groups are sufficient).
Exclusion criteria: Bacterial or viral acute inflammation of the upper respiratory system, chronic obstruction of one or both nostrils with significant deformation of the septum, surgery on the nose or nasal septum within one month of the start of the study
Isotonic seawater:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50 healthy adult athletes between the ages of 18 and 35 will be engaged in the research (power analysis with 80% power and an alpha error of 5% shows that 32 subjects in two groups are sufficient).
排除标准
- •Bacterial or viral acute inflammation of the upper respiratory system, chronic obstruction of one or both nostrils with significant deformation of the septum, surgery on the nose or nasal septum within one month of the start of the study
结局指标
主要结局
Peak nasal inspiratory flow
时间窗: Prior to excercise, on the first day after training and on the seventh day after training.
The primary outcome measures will be nasal airflow measured with a peak nasal inspiratory flow meter (PNIF).
NOSE questionnaire
时间窗: Prior to excercise, on the first day after training and on the seventh day after training.
Subjective impression of symptoms of nasal obstruction before and after exercise by completing the NOSE questionnaire. The NOSE contains five statements about nasal obstruction, divided on a 4-point Likert scale for each statement.
次要结局
未报告次要终点
研究者
Andro Košec, MD, PhD
Assistant Professor
University Hospital Sestre Milosrdnice